The following data is part of a premarket notification filed by Ge Medical Systems with the FDA for Stenoscop Mobile Fluoroscopic Xray System.
| Device ID | K933447 |
| 510k Number | K933447 |
| Device Name: | STENOSCOP MOBILE FLUOROSCOPIC XRAY SYSTEM |
| Classification | Image-intensified Fluoroscopic X-ray System, Mobile |
| Applicant | GE MEDICAL SYSTEMS PO BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Monica Morrison GE MEDICAL SYSTEMS PO BOX 7550 Madison, WI 53707 |
| Product Code | OXO |
| CFR Regulation Number | 892.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-13 |
| Decision Date | 1993-08-23 |
| Summary: | summary |